Evidence map›Paper›PMID 35766811›Full record

Trial reportRheumatology (Oxford, England)2023

Guselkumab provides sustained domain-specific and comprehensive efficacy using composite indices in patients with active psoriatic arthritis.

Laura C Coates, Christopher T Ritchlin, Laure Gossec, Philip S Helliwell, Proton Rahman, Alexa P Kollmeier, Xie L Xu, May Shawi, Chetan S Karyekar, Christine Contré and 5 more

2 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.2field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03158285 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects With Active Psoriatic Arthritis

TypeinterventionalSponsorJanssen Research & Development, LLCRan2017 to 2020Enrolled741ConditionsArthritis, PsoriaticArmsGuselkumab, Placebo
NCT03162796 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti-TNF Alpha Agents

TypeinterventionalSponsorJanssen Research & Development, LLCRan2017 to 2019Enrolled383ConditionsArthritis, PsoriaticArmsGuselkumab, Placebo
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 11 institutions in 5 countries.

Laura C CoatesNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.ORCID 0000-0002-4756-663X
Christopher T RitchlinDepartment of Medicine, Allergy/Immunology and Rheumatology, University of Rochester Medical Center, Rochester, NY, USA.
Laure GossecDepartment of Rheumatology, Institut Pierre Louis d'Epidémiologie et de Santé Publique, INSERM, Sorbonne Université, Paris.
Philip S HelliwellLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
Proton RahmanDiscipline of Medicine, Division of Rheumatology, Craig L Dobbin Genetics Research Centre, Memorial University of Newfoundland, St Johns, NL, Canada.
Alexa P KollmeierDepartment of Immunology, Janssen Research & Development, LLC, San Diego, CA.
Xie L XuDepartment of Immunology, Janssen Research & Development, LLC, San Diego, CA.
May ShawiImmunology, Rheumatology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham.
Chetan S KaryekarDepartment of Immunology, Janssen Research & Development, LLC, Spring House, PA, USA.
Christine ContréJanssen Cilag, Issy-les-Moulineaux, Île-de-France, France.
Wim NoëlDepartment of Immunology, Janssen Scientific Affairs, LLC, Brussels, Belgium.
Shihong ShengDepartment of Statistics and Decision Sciences, Immunology, Janssen Research & Development, LLC, Spring House, PA.
Yanli WangDepartment of Statistics and Decision Sciences, Immunology, Janssen Research & Development, LLC, Spring House, PA.
Stephen XuDepartment of Statistics and Decision Sciences, Immunology, Janssen Research & Development, LLC, Spring House, PA.
Philip J MeaseDepartment of Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health.ORCID 0000-0002-6620-0457
Decision Sciences (United States) · USJanssen (United States) · USInserm · FRJanssen (Belgium) · BEJanssen (France) · FRJohnson & Johnson (United States) · USMemorial University of Newfoundland · CANuffield Orthopaedic Centre · GBProvidence College · USUniversity of Leeds · GBUniversity of Rochester Medical Center · US

Funding

Department of Health
6 · The paper itself

Abstract

objectivesTo evaluate the efficacy of guselkumab for the treatment of active PsA utilizing composite indices.

methodsData were pooled from the phase 3 DISCOVER-1 (n = 381) and DISCOVER-2 (n = 739) studies. In both studies, patients were randomized 1:1:1 to subcutaneous guselkumab 100 mg every 4 weeks (Q4W); guselkumab 100 mg at week 0, week 4, then Q8W; or placebo Q4W with crossover to guselkumab 100 mg Q4W at week 24. Composite indices used to assess efficacy through week 52 included Disease Activity Index for Psoriatic Arthritis (DAPSA), Psoriatic Arthritis Disease Activity Score (PASDAS), minimal disease activity (MDA), and very low disease activity (VLDA). Through week 24, treatment failure rules were applied. Through week 52, non-responder imputation was used for missing data.

resultsGreater proportions of guselkumab- than placebo-treated patients achieved DAPSA low disease activity (LDA) and remission, PASDAS LDA and VLDA, MDA, and VLDA at week 24 vs placebo (all unadjusted P < 0.05). At week 52, in the guselkumab Q4W and Q8W groups, respectively, response rates were as follows: DAPSA LDA, 54.2% and 52.5%; DAPSA remission, 18.2% and 17.6%; PASDAS LDA, 45.3% and 41.9%; PASDAS VLDA, 16.9% and 19.5%; MDA, 35.9% and 30.7%; and VLDA, 13.1% and 14.4%. In the placebo-crossover-to-guselkumab group, response rates for all composite indices increased after patients switched to guselkumab, from week 24 through week 52.

conclusionTreatment with guselkumab provided robust and sustained benefits across multiple PsA domains through 1 year, indicating that guselkumab is an effective therapy for the diverse manifestations of PsA.

trial registrationNCT03162796; NCT03158285.

Indexed as

Antirheumatic AgentsArthritis, PsoriaticAntibodies, Monoclonal, HumanizedHumansSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedAntirheumatic Agentsguselkumabcomposite indicesguselkumabjoint diseasePsAremissionskin clearance

Identifiers

PMID35766811
PMCPMC9891416
OpenAlexW4283718817

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.